FDA approves REMS for Nuvigil, Provigil

FRAZER, Pa. The Food and Drug Administration has approved risk evaluation and mitigation strategies for two sleep disorder drugs made by Cephalon, the drug maker said.

Cephalon announced that the FDA approved the REMS for Nuvigil (armodafinil) and Provigil (modafinil), both used to improve wakefulness in patients with sleep apnea, narcolepsy or shift work disorder.

The goal of each REMS is to inform healthcare providers, caregivers and patients about the risk of serious skin rash and hypersensitivity associated with the drugs. The label for each drug includes a bolded warning for serious, life-threatening rashes that would require hospitalization and discontinuation of treatment.